Skin Diseases, BacterialREAL-DALNCT04485676
Dalbavancin in Real Clinical Practice in Spain
An observational study of Skin Diseases, Bacterial and Skin Diseases, Infectious, run by Angelini Farmacéutica at 7 sites in Spain.
Trial summary
The aim of this study is to describe the real clinical use of Dalbavancin in Spain between January 2018 and December 2019. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Diseases, Bacterial, Skin Diseases, Infectious
- How many people
- 187 participants
- Where
- 7 sitesSpain
- Study dates
- 15 Jul 2020to 21 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with dalbavancin from 1st January 2018 to 31st December 2019
Who may be able to join
- Adult man and woman (≥ 18 years) at the time of receiving dalbavancin
- Patients receiving at least one dose of dalbavancin between 1st January 2018 and 31st December 2019
- Patients with medical follow-up information registered in clinical records for about 90 days after completing the treatment
- Written informed consent requested according to local regulation, IEC and protocol requirements
Who cannot join
- 1. Patient enrolled in a clinical trial in which treatment with dalbavancin is managed through a protocol
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Universitario A Coruña
A Coruña, 15006
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
Hospital Clínic Barcelona
Barcelona, 08036
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universtario La Fe
Valencia, 46026
About this study
Official title: Dalbavancin in Real Clinical Practice in Spain: a Two-year Retrospective Study
The aim of this study is to describe the real clinical use of Dalbavancin in Spain between January 2018 and December 2019.
Read the detailed description
Dalbavancin is a new lipoglycopeptide approved for the treatment of ABSSSIs (Acute Bacterial Skin and Skin-Structure Infections) with activity against Gram-positive pathogens, including MRSA. Dalbavancin has unique pharmacokinetics properties, with a terminal half-life of 14.4 days, permitting a single intravenous dosing. Dalbavancin has shown a favourable efficacy and safety profile in patients with ABSSSI in randomized controlled trials. However, information regarding daily clinical practice is limited. The main objective of this study is to describe the real clinical practice with Dalbavancin in Spain.
- Medical subject headings
- Skin Diseases, Bacterial, Skin Diseases, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dalbavancin | Patients to be included in this study have been treated with Dalbavancin according to clinician's judgement and clinical practice according national or international guidelines. Dalbavancin is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Information about dosing treatment will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic and clinical characteristics of patients treated with dalbavancin
To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective)
Measured: patients treated with dalbavancin between January 2018 and December 2019
Variables related to dalbavancin treatment
To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective)
Measured: patients treated with dalbavancin between January 2018 and December 2019
Secondary outcomes (6)
Effectiveness/Clinical response
Clinical response (signs and symptoms) evaluated at the end of treatment
Measured: From 48-72h after the end of treatment until 90 days after last dose of dalbavancin
Effectiveness/Relapse
Relapse (Yes/No)
Measured: 90 days after after last dose of dalbavancin
Safety. Adverse events
Rate of adverse events Rate of treatment discontinuation due to Adverse events
Measured: From first dose until 90 days after last dose of dalbavancin
Treatment compliance
Patient received the full dose of dalbavancin (Yes/No)
Measured: : From first dose until 90 days after last dose of dalbavancin
Doctors opinion on infection management with dalbavancin (1)
Degree of physician satisfaction on management with dalbavancin: Dissatisfied, Little satisfied, Satisfied, Very satisfied
Measured: From first dose until 90 days after last dose of dalbavancin
Doctors opinion on infection management with dalbavancin (2)
Physician assessment on potential reduction in the number of days of hospital stay (Yes/No)
Measured: From first dose until 90 days after last dose of dalbavancin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start15 Jul 2020
- Primary completion31 Dec 2020
- Study completion21 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Diseases, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angelini Farmacéutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Responsible party
- Sponsor
- Investigators
- Benito Almirante, PhD, Principal investigator, Hospital Vall d'Hebrón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485676
- Sponsor's protocol ID
- ANG-DAL-2019-01
- Acronym
- REAL-DAL
- Status last verified
- May 2021
- First submitted
- 16 Jun 2020
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dalbavancin in Real Clinical Practice in Spain: a Two-year Retrospective Study
- ClinicalTrials.gov ID
- NCT04485676
- Acronym / sponsor ID
- REAL-DAL / ANG-DAL-2019-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Angelini FarmacéuticaIndustry (pharma, biotech, devices)
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 21 Feb 2021 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to describe the real clinical use of Dalbavancin in Spain between January 2018 and December 2019.
Detailed description
Dalbavancin is a new lipoglycopeptide approved for the treatment of ABSSSIs (Acute Bacterial Skin and Skin-Structure Infections) with activity against Gram-positive pathogens, including MRSA. Dalbavancin has unique pharmacokinetics properties, with a terminal half-life of 14.4 days, permitting a single intravenous dosing. Dalbavancin has shown a favourable efficacy and safety profile in patients with ABSSSI in randomized controlled trials. However, information regarding daily clinical practice is limited. The main objective of this study is to describe the real clinical practice with Dalbavancin in Spain.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dalbavancin | – | –Patients to be included in this study have been treated with Dalbavancin according to clinician's judgement and clinical practice according national or international guidelines. Dalbavancin is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Information about dosing treatment will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with dalbavancin from 1st January 2018 to 31st December 2019
Key inclusion criteria (4 listed)
- Adult man and woman (≥ 18 years) at the time of receiving dalbavancin
- Patients receiving at least one dose of dalbavancin between 1st January 2018 and 31st December 2019
- Patients with medical follow-up information registered in clinical records for about 90 days after completing the treatment
- Written informed consent requested according to local regulation, IEC and protocol requirements
Key exclusion criteria (1 listed)
- 1. Patient enrolled in a clinical trial in which treatment with dalbavancin is managed through a protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic and clinical characteristics of patients treated with dalbavancin
Time frame: patients treated with dalbavancin between January 2018 and December 2019
To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective)
Variables related to dalbavancin treatment
Time frame: patients treated with dalbavancin between January 2018 and December 2019
To describe the demographic and clinical characteristics of patients treated with dalbavancin (primary objective)
6 secondary outcomes
Effectiveness/Clinical response
Time frame: From 48-72h after the end of treatment until 90 days after last dose of dalbavancin
Effectiveness/Relapse
Time frame: 90 days after after last dose of dalbavancin
Safety. Adverse events
Time frame: From first dose until 90 days after last dose of dalbavancin
Treatment compliance
Time frame: : From first dose until 90 days after last dose of dalbavancin
Doctors opinion on infection management with dalbavancin (1)
Time frame: From first dose until 90 days after last dose of dalbavancin
Doctors opinion on infection management with dalbavancin (2)
Time frame: From first dose until 90 days after last dose of dalbavancin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benito Almirante, PhD principal investigator
Hospital Vall d'Hebrón
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Diseases, Bacterial and Skin Diseases, Infectious, run by Angelini Farmacéutica at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic and clinical characteristics of patients treated with dalbavancin (time frame: patients treated with dalbavancin between January 2018 and December 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.